Ventilation Therapy; Complications
Conditions
Keywords
Bag Mask Ventilation
Brief summary
The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation
Interventions
DEVICETTIP ventilation
In TTIP ventilation, an endotracheal tube is inserted via the nostril or oral cavity and subsequently advanced until the tip of the tube reaches approximately the level of the glottis.
DEVICEMask Ventilation
In mask ventilation, a mask is placed over the nose and mouth.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI \>30 kg/m2 * Mallampati class III or IV * Requiring general anesthesia
Exclusion criteria
* Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD)and asthma * American Society of Anesthesiologists (ASA)physical status classification ≥IV * Emergency surgery * Induction requiring rapid sequence for intubation * Patients requiring awake intubation * Pregnant women * Untreated ischemic heart disease * Contraindication for mask ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Successful Ventilation | from start of ventilation to end of ventilation (about 1 minute) | Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expired Tidal Volume of Ventilation | from start of ventilation to end of ventilation (about 1 minute) | This is measured by readings from the ventilator used in the operating room |
| Peak Inspiratory Airway Pressure Achieved | from start of ventilation to end of ventilation (about 1 minute) | This is measured by readings from the ventilator used in the operating room |
| Dynamic Airway Resistance | from start of ventilation to end of ventilation (about 1 minute) | This is defined as the peak inspiratory flow divided by the corresponding airway pressure. |
| Satisfaction of the Providers Obtained With Post Ventilation Survey | Baseline before start of surgery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TTIP Ventilation, Then Mask Ventilation Subjects will first be ventilated with the TTIP technique. If the subjects are adequately ventilated, as defined by carbon dioxide measured during exhalation in at least one of the first three consecutive breaths, ventilation will continue until completion of 10 breaths, for 1 min (Step 1).Subjects will then be ventilated with mask ventilation (Step 2).In Step 1, if ventilation fails with the TTIP technique for all of the first three consecutive breaths, the subject will be crossed over to the mask ventilation. If ventilation fails again with all the first three consecutive breaths after crossover,the study will be terminated.The routine care is resumed including tracheal intubation or laryngeal mask airway (LMA) insertion.
TTIP ventilation: In TTIP ventilation, an endotracheal tube is inserted via the nostril or oral cavity and subsequently advanced until the tip of the tube reaches approximately the level of the glottis.
Mask Ventilation: In mask ventilation, a mask is placed over the nose and mouth. | 76 |
| Mask Ventilation, Then TTIP Ventilation Subjects will first be ventilated with the mask technique. If the subjects are adequately ventilated, as defined by carbon dioxide measured during exhalation in at least one of the first three consecutive breaths, ventilation will continue until completion of 10 breaths, for 1 min (Step 1).Subjects will then be ventilated with TTIP technique (Step 2).In Step 1, if ventilation fails for all of the first three consecutive breaths, the subject will be crossed over to the TTIP ventilation. If ventilation fails again with all the first three consecutive breaths after crossover,the study will be terminated.The routine care is resumed including tracheal intubation or LMA insertion.
TTIP ventilation: In TTIP ventilation, an endotracheal tube is inserted via the nostril or oral cavity and subsequently advanced until the tip of the tube reaches approximately the level of the glottis.
Mask Ventilation: In mask ventilation, a mask is placed over the nose and mouth. | 71 |
| Total | 147 |
Baseline characteristics
| Characteristic | TTIP Ventilation, Then Mask Ventilation | Mask Ventilation, Then TTIP Ventilation | Total |
|---|---|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 14.8 | 44.4 years STANDARD_DEVIATION 13 | 46.2 years STANDARD_DEVIATION 14 |
| American Society of Anesthesiology (ASA) Classification ASA I :A normal healthy patient | 2 Participants | 2 Participants | 4 Participants |
| American Society of Anesthesiology (ASA) Classification ASA II :A patient with mild systemic disease | 31 Participants | 35 Participants | 66 Participants |
| American Society of Anesthesiology (ASA) Classification ASA III: A patient with severe systemic disease | 43 Participants | 33 Participants | 76 Participants |
| American Society of Anesthesiology (ASA) Classification ASA IV: A patient with severe systemic disease that is a constant threat to life | 0 Participants | 1 Participants | 1 Participants |
| American Society of Anesthesiology (ASA) Classification ASA V: A moribund patient who is not expected to survive without the operation | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiology (ASA) Classification ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index (BMI) < 30 kg/m^2 | 4 Participants | 3 Participants | 7 Participants |
| Body Mass Index (BMI) ≥ 40 kg/m^2 (Class 3 obesity) | 17 Participants | 14 Participants | 31 Participants |
| Body Mass Index (BMI) greater than or equal to 30 kg/m^2 to less than 40 kg/m^2(Class 1&2 obesity) | 55 Participants | 54 Participants | 109 Participants |
| Body Mass Index (BMI) | 36.1 kg/m^2 STANDARD_DEVIATION 7.3 | 36.6 kg/m^2 STANDARD_DEVIATION 6 | 36.3 kg/m^2 STANDARD_DEVIATION 6.7 |
| Mallampati Class Class III: only the soft palate and base of the uvula are visible | 19 Participants | 16 Participants | 35 Participants |
| Mallampati Class Class II: soft palate and uvula are visible | 26 Participants | 34 Participants | 60 Participants |
| Mallampati Class Class I: soft palate, uvula, and pillars are visible | 24 Participants | 17 Participants | 41 Participants |
| Mallampati Class Class IV: only the hard palate is visible | 7 Participants | 4 Participants | 11 Participants |
| Provider's training levels Anesthesia assistants | 19 Participants | 17 Participants | 36 Participants |
| Provider's training levels Anesthesia residents | 48 Participants | 46 Participants | 94 Participants |
| Provider's training levels Attending Anesthesiologists | 9 Participants | 8 Participants | 17 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 76 participants | 71 participants | 147 participants |
| Sex: Female, Male Female | 44 Participants | 37 Participants | 81 Participants |
| Sex: Female, Male Male | 32 Participants | 34 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 147 | 0 / 147 |
| other Total, other adverse events | 0 / 147 | 0 / 147 |
| serious Total, serious adverse events | 0 / 147 | 0 / 147 |
Outcome results
Primary
Number of Patients With Successful Ventilation
Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.
Time frame: from start of ventilation to end of ventilation (about 1 minute)
Population: Data were not collected for 11 participants in the TTIP Ventilation arm and the Mask ventilation arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TTIP Ventilation | Number of Patients With Successful Ventilation | 127 Participants |
| Mask Ventilation | Number of Patients With Successful Ventilation | 115 Participants |
Secondary
Dynamic Airway Resistance
This is defined as the peak inspiratory flow divided by the corresponding airway pressure.
Time frame: from start of ventilation to end of ventilation (about 1 minute)
Population: Data were not collected for this outcome measure.
Secondary
Expired Tidal Volume of Ventilation
This is measured by readings from the ventilator used in the operating room
Time frame: from start of ventilation to end of ventilation (about 1 minute)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TTIP Ventilation | Expired Tidal Volume of Ventilation | 618.22 ml | Standard Deviation 313.68 |
| Mask Ventilation | Expired Tidal Volume of Ventilation | 719.48 ml | Standard Deviation 348.64 |
Secondary
Peak Inspiratory Airway Pressure Achieved
This is measured by readings from the ventilator used in the operating room
Time frame: from start of ventilation to end of ventilation (about 1 minute)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TTIP Ventilation | Peak Inspiratory Airway Pressure Achieved | 19.82 cmH2O | Standard Deviation 1.11 |
| Mask Ventilation | Peak Inspiratory Airway Pressure Achieved | 19.94 cmH2O | Standard Deviation 1.76 |
Secondary
Satisfaction of the Providers Obtained With Post Ventilation Survey
Time frame: Baseline before start of surgery
Population: Data were not collected for this outcome measure.
Secondary
Satisfaction of the Providers Obtained With Post Ventilation Survey
Time frame: end of surgery (about 1 hour after start)
Population: Data were not collected for this outcome measure.